LÉO RAMOS CHAVES, WITH PRODUCT BY BIOARCHITECTS
The FDA published a 31-page document with guidance on the use of 3D printingLÉO RAMOS CHAVES, WITH PRODUCT BY BIOARCHITECTSOn December 5, the US Food and Drug Administration (FDA) published new technical guidelines on the 3D printing of medical products, an extremely promising field that is expected to grow rapidly over the coming years. The new guidelines are intended for the industry and for the FDA itself, and were finalized following a review of more than 100 devices currently on the American market that were manufactured on 3D printers. These include organ implants tailored to fit a patient’s specific anatomy, such as knee replacements, as well as 3D-printed anti-seizure drugs that are absorbed by the body faster than conventionally manufactured medication. “The recommendations clarify what the FDA recommends manufacturers include in submissions for 3D-printed medical products,” said Scott Gottlieb, the agency’s director, in a statement released to the press. “They include our thinking on various approaches to 3D printing, including device design, testing of products for function and durability, and quality system requirements.”
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